Cartilage Damage, Cartilage Injury, Defect of Articular Cartilage
Conditions
Keywords
focal defect, focal lesion, chondral lesion, osteochondral lesion
Brief summary
Information will be collected on the pre-op and post-op clinical status of patients with focal cartilage defects of the femoral condyles treated with the BioPoly RS Partial Resurfacing Knee Implant, a permanent orthopaedic implant. The overall aim of the study is to increase the knowledge of patient outcomes such as pain, knee function, level of activity, and overall quality of life after treatment with the device.
Detailed description
Information will be collected on the pre-op and post-op clinical status of patients with focal cartilage defects of the femoral condyles treated with the BioPoly RS Partial Resurfacing Knee Implant, a permanent orthopaedic implant. The overall aim of the study is to increase the knowledge of patient outcomes such as pain, knee function, level of activity, and overall quality of life after treatment with the device. Patients will be followed for 5 years after surgery.
Interventions
DEVICEBioPoly RS Partial Resurfacing Knee Implant
A long term, surgically invasive device for replacement of focal osteochondral defects in the weight bearing region of the femoral condyles.
Sponsors
BioPoly LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cartilage lesion located in weight bearing region of medial or lateral femoral condyles that have failed prior therapy (conservative or surgical) * Lesion classified as ICRS Grade 2, 3, or 4
Exclusion criteria
* Body mass index (BMI) of 30 or more * Osteoarthritis or rheumatoid arthritis * Gout * Uncorrected mal-alignment, ligamentous instability, or meniscal tear * Total meniscectomy * Kissing lesion on tibia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | 6 months | Knee function assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Through 5 years | Knee function assessment |
| VAS Pain | Through 5 years | Visual analogue scale for assessment of pain |
| Tegner Activity | Through 5 years | Measurement of patient's activity level |
| SF-36 | Through 5 years | Assessment of patient's overall quality of life |
Countries
United Kingdom
Outcome results
None listed